GREEN SPEED Việt Nam ★ 3.4

1. Program Leadership & Governance

• Establish the EU GMP certification readiness strategy and roadmap.

• Provide overall governance for GMP readiness activities across all functional areas.

• Ensure alignment between business objectives, regulatory expectations, and operational execution.

• Drive accountability across workstream leaders for commitments, milestones, and deliverables.

• Lead executive communications and updates to Site leadership team.
• Coordinate with other workstream leaders and Site leadership team to assure the defined CAPA completion and the milestone achievement.

2. PMO & Compliance Leadership

• Provide strategic leadership and governance for the EU GMP PMO and compliance management framework.
• Establish oversight mechanisms to ensure the effectiveness of the integrated master plan, milestone management, action tracking, risk governance, compliance reporting, and escalation pathways.
• Review of critical program risks, priorities, and dependencies, ensuring timely escalation for decision-making and removal of barriers through appropriate stakeholder engagement.
• Champion cross-functional alignment, governance discipline, and escalated to Site leadership team for resource prioritization to support GMP readiness objectives.
• Accountability for program transparency, compliance progress, and executive-level reporting.

3. Performance Monitoring & Continuous Improvement Leadership

• Define the framework and strategic direction for GMP readiness performance measurement and KPI governance.
• Provide oversight of compliance performance, trend analysis, overdue actions, and effectiveness of corrective and preventive measures.

4. Inspection Readiness & Regulatory Excellence

• Establish and maintain a state of continuous inspection readiness.

• Organize mock inspections, leadership coaching, SME preparation, front room and back room management, and regulatory response readiness.

• Ensure timely and effective observation response and remediation.

5. Risk Management & Escalation

• Establish risk-based decision-making processes and maintain the enterprise-level GMP risk register.

• Identify critical compliance gaps and drive timely mitigation.

• Escalate high-risk issues to Site leadership team and ensure risk ownership and closure accountability across workstreams.

Key Deliverables

• Successful EU GMP certification readiness.
• Inspection-ready state maintained at all times.
• Integrated EU GMP readiness dashboard.
• Effective governance and risk management process.
• Timely closure of critical compliance gaps.
• Sustainable GMP compliance framework.
• Positive regulatory inspection outcomes.
• Executive visibility of program performance and risks.

• Bachelor's degree in Pharmacy, Biotechnology, Quality, or equivalence.
• Proven leadership of complex GMP remediation, transformation, inspection readiness, or regulatory compliance programs.
• Direct experience supporting EU GMP inspections and regulatory agency interactions.
• Deep knowledge of: EU GMP, ICH Guidelines, Data Integrity, Validation and Qualification, Quality Systems, Pharmaceutical Manufacturing Operations
• Strong understanding of risk management and compliance governance
• Strategic Leadership
• Fluent in English-4 skills